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Industry News and Press: Regulatory Updates

March 2018 Regulatory Update

Sunday, April 1, 2018   (0 Comments)
These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from March 1, 2018 through March 31, 2018.  Please contact Seth Mailhot, Leah Ziemba, or Paulette M. Mara for additional information on regulatory issues that may impact upon your business.

The March 2018 Regulatory Update includes several MUST READ updates, including FDA Announces Major Nutritional Labeling Initiative: Declaring Added Sugar in Certain Products, Small Entity Compliance Guide to Nutritional Labeling and Guidance Document for Nutritional Labeling; Food Safety Modernization Act (FSMA) Updates; Other Developments of Interest


Gottlieb Announces Major Nutritional Initiative at National Food Policy Conference

In a recent speech to the National Food Policy, FDA Commissioner Scott Gottlieb announced the launch of FDA’s Nutrition Innovation Strategy. In a release, FDA stated that the agency "has identified several areas where it believes there is opportunity to improve public health and encourage innovation” including addressing labeling claims, ingredient disclosure, and standards of identity. 

The proposal drawing the most media interest is potential change to the rules governing the use of the "healthy” claim. 

"‘Healthy’ is one claim we believe is ripe for change,” Gottlieb said, noting the agency has already signaled its intention to update the criteria for this claim. "Having a one-word claim such as ‘healthy’ that’s based on current science would make it even easier for busy consumers, including me, to make choices that can help build more healthful diets.”

Gottlieb also announced that the agency may pursue a standard icon or symbol for the word "healthy.” Such a symbol would allow consumers to easily find the claim, he said. 

FDA and Gottlieb emphasized the development of the agency’s nutritional strategy will involve future opportunities for input from stakeholders and the public. >>FDA Update  >>Read the Speech

Gottlieb Releases Statement on Advancing Implementation of New Nutrition Facts Label MUST READ

FDA Commissioner Dr. Scott Gottlieb released a statement on March 1, 2018, relating to FDA’s "new efforts to advance implementation of the new consumer Nutrition Facts label.” The statement was released in connection with the agency’s announcement of five guidance documents that FDA says will "provide further clarity on several key elements, including fiber, added sugars and serving size declarations.” Those five guidance documents (one draft guidance and four final documents) are covered in this month’s Regulatory Update. 

In his statement, Gottlieb also announced the launch of an educational campaign to help Americans use the new version of the Nutrition Facts label and interpret the overall content of products they find on supermarket shelves. >>Read more

FDA Draft Guidance on Declaring Added Sugars in Honey, Maple Syrup, Certain Cranberry Products

On March 1, 2018, FDA announced the availability of Draft Guidance entitled "The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products.” The draft guidance announces FDA’s intent to exercise enforcement discretion "related to the use in the Nutrition Facts label of a symbol ‘†’ immediately after the added sugars percent Daily Value information on single ingredient packages and/or containers of pure honey or pure maple syrup and on certain dried cranberry and cranberry juice products.” Specifically, for pure honey, pure maple syrup, and certain dried cranberry and cranberry juice products "that contain total sugars at levels no greater than comparable products with endogenous (inherent) sugars, but no added sugars,” a dagger symbol could "direct consumers to truthful and non-misleading statements on the package outside the Nutrition Facts label.” 

In the case of pure honey and maple syrup, FDA states that its guidance responds to stakeholder concerns that consumers could "misinterpret the added sugars declaration to mean that non-endogenous sweeteners, such as corn syrup or cane sugar, have been added to the pure product.” In the case of certain cranberry products, FDA noted that certain cranberry products have added sugars added to them to "bring the total sugars per serving up to levels comparable to the levels of non-cranberry competitor products that contain equivalent amounts of total sugars, but whose labels list zero ‘added sugars’ because their fruit products are inherently sweet.” The draft guidance provides example statements that may address these concerns.

Comments should be submitted by May 1, 2018. >>Read more

FDA Guidance on Honey and Honey Products Labeling

March 1 also brought the release of FDA guidance on "the proper labeling of honey and honey products” under the Food, Drug, and Cosmetic Act and its implementing regulations. The guidance, presented in a question-and-answer format, includes information on the naming of honey, how honey must be labeled if it contains sweeteners, flavorings, or other ingredients, and information on FDA’s enforcement authority in this area. >>Read more

FDA Releases Small Entity Compliance Guide for Food Labeling Issues

On March 1, 2018, FDA announced the availability of a Small Entity Compliance Guide covering certain food labeling requirements. The Compliance Guide is intended to restate the requirements of FDA’s May 2016 final rule "pertaining to serving sizes for food” in plain language. See 81 FR 34000. FDA intends the guide to aid small entities in complying with the 2016 rule. >>Read more

FDA Releases List of Products Categories for Nutritional Labeling Serving Size

On March 1, 2018, FDA announced the availability of guidance titled "Reference Amounts Customarily Consumed: List of Products for Each Product Category.” FDA regulations establish Reference Amounts Customarily Consumed (RACCs) on a "product category” basis. See 21 CFR 101.12(b). Per FDA, food manufacturers "can use RACCs to determine the required label serving size” for nutrition information labels. In May 2016, FDA published a final rule that, among other things, amended some existing RACCs and established RACCs for new product categories. See 81 FR 34000. This guidance builds on the "product categories” found in the rule by providing "additional examples of products that belong in each of the product categories for which a RACC has been established.” The product lists are not all-inclusive. >>Read more


Draft Guidance: Determining the Number of Employees for Purposes of the "Small Business” Definition of the FSMA Rules for Preventive Controls for Human and Animal Food - MUST READ

On March 20, 2018, FDA released draft guidance designed to help regulated entities determine the number of employees they have for purposes of the FSMA Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls for human and animal food rules. As FDA notes in the draft guidance, the whether an entity is a "small business” impacts the entity’s compliance date under both the CGMP/preventive control rules and may also affect the eligibility of certain entities (such as "farm mixed-type facilities”) for an exemption from the rules. Under the two rules, a "Small Business” cannot generally have 500 or more full-time equivalent employees. Presented in a question-and-answer format, the draft guidance provides a step-by-step model for calculating how many FTEs the business has for this purpose. 

Comments should be submitted by May 21, 2018 to ensure they are considered by FDA. >>Read more

FDA Intends to Exercise Enforcement Discretion Relating to Application of the Foreign Supplier Verification Program Regulation to Importers of Certain Live Animals

In Guidance to Industry announced on March 22, 2018, FDA announces its intent to exercise enforcement discretion relating to the application of the FSMA Foreign Supplier Verification Program (FSVP) rule to certain importers of animals. Specifically, FDA intends to exercise discretion with respect to importers of live animals that "are required to be slaughtered and processed at U.S. Department of Agriculture (USDA)-regulated establishments subject to USDA-administered hazard analysis and critical control point (HACCP) requirements” or "at state-inspected establishments subject to requirements equivalent to the federal standards.” The guidance acknowledges that USDA’s oversight of these facilities ensures that "hazards associated with the live animals processed at such establishments ordinarily would be identified and controlled and the food resulting from the slaughter and processing of those live animals could not be consumed without such controls.” >>Read more

FDA Holds Summit on Agricultural Water Issues Related to Microbial Quality, On-Farm Water

In a recent blog post, FDA touted the collaborative approach it is taking to implementing FSMA provisions, specifically highlighting a recent two-day summit on the topic of agricultural water. FSMA’s Produce Safety Rule includes "standards for microbial quality and testing of agricultural water that comes into direct contact with the harvestable portion of produce.” The blog notes that stakeholders have expressed concerns that these standards "may be too complex to understand and implement.” Samir Assar, Director of FDA’s Division of Produce Safety, wrote that there was a consensus among summit attendees that it is time to agree on next steps and noted that the agency needs more information relating to "on-farm conditions and water systems.” >>Read more

FDA Addresses Efforts to Guard Against Intentional Adulteration of Food Products - MUST READ

FDA Commissioner Scott Gottlieb recently authored a blog discussing FDA’s efforts to prevent "intentional adulteration” of food products, specifically highlighting the FSMA Intentional Adulteration rule, noting that this rule will require large food facilities to implement "a food defense plan that identifies vulnerabilities and ways to reduce the risk of intentional adulteration.” >>Read more

FSMA FSVP Compliance Dates 

As we’ve noted in a previous update, FSMA granted FDA new authority to "better insure that imported products meet U.S. standards and are safe for U.S. consumers.” The final rule for FSMA’s Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals was finalized in November 2015. In general, the FSVP requires "importers to perform certain risk-based activities to verify that food imported into the United States has been produced in a manner than meet applicable U.S. safety standards.” Compliance dates for importers subject to the FSVP rule vary based upon the size of the foreign supplier, the nature of the importer, and whether the foreign supplier is subject to FSMA final rules for:  

  • Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food,
  • Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (collectively, "PC rules”), or
  • Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption ("produce safety rule”).

On a key FSVP compliance date, March 19, 2018, FSVP requirements went into effect for three additional categories of importers: FSVP importers whose foreign supplier is a Small Business (as defined by regulation) and is required to comply with the PC rule for human food;

  • FSVP importers of animal food whose foreign supplier is a Small Business and is subject to the Current Good Manufacturing Practices (CGMPs) in the PC rule from animal food; and
  • FSVP importers of animal food whose large-business foreign supplier is subject to animal food preventative control requirements, but that is not required to comply with CGMPs for animal food. 

FDA recently announced that it does not intend to enforce certain FSMA rules. Related to the FSVP requirements, FDA announced it will not enforce certain "requirements related to written assurances from a manufacturer’s customers, requirements for importers of food contact substances[.]” 

Compliance Dates - MUST READ

The FSMA Sanitary Transportation of Food compliance date for Small Business was April 6, 2018. >>Read more

A compilation of key FSMA dates is available here


FDA Seeks Comment on Registration Requirements for Calorie/Menu Labeling Rule

In 2014, FDA updated regulations at 21 CFR Part 101 relating to calorie labeling of food products in vending machines and nutritional labeling of standard menu items in restaurants and similar retail food establishments. See 79 FR 71156, 71259. These regulations provided "for the nutritional analysis of certain foods and for the disclosure of that information on applicable products purchased by consumers” and included provisions relating to the "registration of certain individuals” subject to the labeling requirements. In a notice published March 28, 2018, FDA announced that it was seeking additional comments on its proposed approach to this registration requirement, including the registration form (Form 3757, DHHS FDA Menu and Vending Machine Labeling Voluntary Registration) that FDA has developed. Comments should be submitted by no later than April 27, 2018. >>Read more

FDA Seeks Comment Relating to ‘‘Foods Derived from New Plant Varieties”

FDA guidance entitled "Guidance on Consultation Procedures: Foods Derived from New Plant Varieties,” sets out the consultation process FDA uses to evaluate information on new plant varieties, with a stated goal of resolving "human food and animal feed safety issues or other regulatory issues” prior to commercial distribution. 

In December 2017, FDA sought comment on its proposal to continue this information-gathering practice and received two comments. Commenters suggested that FDA should "compare efficiencies with a process at the U.S. Department of Agriculture regarding the review of agricultural biotechnology” and consider ways in which the agency could reduce redundancy in the FDA review process. FDA accepts comments on its guidance documents at any time. >>Read more

FDA Releases Voluntary National Retail Food Regulatory Program Standards

On March 7, 2018, FDA released the 2017 Voluntary National Retail Food Regulatory Program Standards. According to FDA’s news release, the program standards "define the key elements of an effective food regulatory program for state, local, tribal, and territorial food regulatory programs.” >>Read more

Reminder - FDA Issues Draft Guidance, "Menu Labeling:  Supplemental Guidance for Industry”

As noted in our recent updates, on November 9, 2017, FDA issued a Draft Guidance, "Menu Labeling: Supplemental Guidance for Industry.” The draft guidance is intended to address concerns raised by stakeholders regarding the implementation of nutrition labeling for foods sold in covered establishments. FDA announced that it "includes expanded and new interpretations of policy, and identifies places where FDA intends to be more flexible in its approach.” 82 FR 50236.  The draft guidance "addresses calorie disclosure signage for self-service foods, including buffets and grab-and-go foods; reasonable basis, and the criteria for considering the natural variation of foods; various methods for providing calorie disclosure information, including those for pizza; compliance and enforcement; and criteria for distinguishing between menus and other information presented to the consumer.”  

The date for compliance with the menu labeling final rule is May 7, 2018. >>Read more

Reminder - FDA Issues Draft Guidance on "Best Practices for Convening a GRAS Panel”

As noted in our recent updates, on November 15, 2017, FDA published a draft guidance, "Best Practices for Convening a GRAS Panel,” intended to assist those persons convening a panel of experts ("GRAS panel”) to evaluate whether the available scientific data, information, and methods establish that a substance is safe under the conditions of its intended use in human food or animal food in relation to the generally recognized as safe (GRAS) provision of the federal Food, Drug and Cosmetic Act. The draft guidance provides best practices to identify the appropriate members of such a panel, address conflict of interest issues, and consider other suggested steps and strategies with respect to such panels. Public comments should be submitted by May 15, 2018. >>Read more

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